Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04836858 | A Study to Assess the Efficacy and Safety of CMK389 in Patients With Moderate to Severe Atopic Dermatitis. | PHASE2 | COMPLETED | 71 | — | — | Apr 20, 2021 | Dec 13, 2022 | Jun 20, 2024 | 18 | Czechia, France +4 |
The Investigator Global assessment (IGA) scale used was vIGA-AD\^TM (Validated Investigator Global Assessment scale for Atopic Dermatitis). The IGA rating scale was used to determine the severity of atopic dermatitis and clinical response to treatment. It reflected a participant's overall disease severity for the whole body based on a 5-point scale. The 5-point scale included: clear, almost clear, mild, moderate, and severe disease. IGA response is defined as clear or almost clear and at least a 2 point-reduction from baseline at week 16.
| Arm | Type | Description |
|---|---|---|
| CMK389 10mg/kg i.v. | EXPERIMENTAL | Active |
| Placebo i.v. | PLACEBO_COMPARATOR | Placebo |
| CMK389 300mg s.c. | EXPERIMENTAL | Active |
| Placebo s.c. | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| CMK389 | BIOLOGICAL | Active |
| Placebo | BIOLOGICAL | Placebo Comparator |
Inclusion Criteria: * Adult male or female participants with chronic atopic dermatitis, aged 18 to 65 years, present for at least 1 year before screening. * Participants with Moderate to severe AD defined by IGA score of ≥ 3 (on a scale of 0 to 4, in which 3 is moderate and 4 is severe) at Baseline...